MFDS: "Korea Maintains Listing on EU 'Whitelist'"

[Asia Economy Reporter Lee Gwan-ju] The Ministry of Food and Drug Safety announced on the 30th that South Korea maintained its status as a listed country in the 'European Union (EU) Whitelist' (countries exempt from GMP written confirmation) after the first regular re-evaluation since its registration.

South Korea was the seventh country in the world to be listed on the EU Whitelist in 2019. By maintaining its status as a listed country this time, it was once again recognized that the domestic pharmaceutical manufacturing and quality management standards, the regulatory system of the Ministry of Food and Drug Safety, and domestic active pharmaceutical ingredient manufacturers are of a global standard.

With the registration on the EU Whitelist, domestic pharmaceutical companies are exempt from submitting GMP written confirmation certificates when exporting active pharmaceutical ingredients to the EU, reducing the required time by more than four months.

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, said, "Maintaining the status as a listed country on the EU Whitelist this time is an international and objective recognition of South Korea's regulatory capabilities and excellence in the pharmaceutical sector," adding, "We will boldly change regulations that hinder domestic companies from competing overseas to 'global standards.'"